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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. PACING/PSI KIT: 5FR/6 FR2-L TEMPORARY PACING CATHETER PRODUCTS

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ARROW INTL., INC. PACING/PSI KIT: 5FR/6 FR2-L TEMPORARY PACING CATHETER PRODUCTS Back to Search Results
Catalog Number AI-07155-IK
Device Problem Fluid Leak
Event Date 08/06/2014
Event Type  Malfunction  
Event Description

It was reported that the event involved a female pt while in the cath lab during insertion of an ai-07155-ik. The doctor inserted the catheter via jugular and blood was observed flowing out of the tuohy-borst lock. As a result, the catheter was removed. A new arrow ai-07155-ik was used. The doctor stated there was no pt death, complications, injury, or medical/surgical intervention required. There was an unk time of delay or interruption in therapy with no harm to the pt noted. The pt outcome was good. Ref mdr# 1036844-2014-00397 for the second event involving the same pt.

 
Manufacturer Narrative

(b)(4). Sample will not be returned for evaluation as it was discarded by the customer.

 
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Brand NamePACING/PSI KIT: 5FR/6 FR2-L
Type of DeviceTEMPORARY PACING CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
kathryn myers, associate
2400 bernville rd
reading , PA 19605
6403780131
MDR Report Key4118838
Report Number1036844-2014-00396
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberAI-07155-IK
Device LOT NumberRF3041913
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/26/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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